Market Updates

The Cell and Gene Therapies approved by US FDA

November, 2018

Gene Therapy is a biomedical research used for changing the development of several genetic and acquired ailments at a small level of the DNA/RNA. A total of 16 cell and gene therapy products are approved by US FDA. Fascinatingly, out of 16 products, eight products, which accounts for almost 50% of these are derived from umbilical cord blood and immunotherapies accounts for 20%, which includes three products.

The total number of cell and gene therapy products permitted by the FDA are as follows:




ALLOCORD (HPC Cord Blood)SSM Cardinal Glennon Children’s Medical CenterIt is used for the distinct donor hematopoietic progenitor cell transplantation procedures in combination with a suitable initial routine for hematopoietic and immunologic re-formation in individuals with illnesses affecting the hematopoietic arrangement that are hereditary, developed, or effect due to myeloablat treatment.
HPC, Cord BloodBloodworks – Bloodworks
HPC, Cord BloodLifeSouth – LifeSouth Community Blood Centers, Inc.,
Ducord, HPC Cord BloodDuke University School of Medicine and
HPC, Cord BloodMD Anderson Cord Blood Bank
HPC, Cord BloodClinimmune Labs, University of Colorado Cord Blood Bank
HEMACORD (HPC, cord blood)New York Blood Center,
CLEVECORD (HPC Cord Blood)Cleveland Cord Blood Center
YESCARTA (axicabtagene ciloleucel) Kite Pharma, Inc.

CD19-directed genetically modified autologous T cell immunotherapy specified for treating adult population with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, together with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
LAVIV (Azficel-T)Fibrocell TechnologiesFor the improvement in adults with moderate to severe nasolabial fold wrinkles

Vericel Corp.

An autologous cellularized scaffold product for the repair of lone or numerous characteristic, full-thickness cartilage defects in knee either with or without bone involvement. This product is used for the adults.
KYMRIAH (tisagenlecleucel)Novartis Pharmaceuticals Corporation

For treating individuals below the age of 25 years suffering with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or later relapse.

Spark Therapeutics, IncAn adeno virus vector-based gene therapy designated for the treating individuals with established biallelic RPE65 mutation-connected retinal dystrophy.
PROVENGE (sipuleucel-T)

Dendreon Corp.For asymptomatic or slightly characteristic metastatic castrate resistant prostate cancer.


Organogenesis IncAn allogeneic cellularized scaffold designated for topical application for the woundbed that is caused due to the surgery during the treatment of mucogingival circumstances in adults.
IMLYGIC (talimogene laherparepvec)BioVex, Inc., a subsidiary of Amgen Inc.Indicated for the local treatment of unrespectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

– Rikitha K Murthy,
Research Analyst,
Infoholic Research